Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05682118
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2022-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The sample size was calculated using effect size (Cohen's d) for the effectiveness of the dynamic coronary roadmap system for the guidance of the iFR and FFR. The effect size was assumed to be 0.4, which is a small to medium effect size. The sample size of 113 participants for each group was estimated to provide 90% power with a 2-sided type I error of 0.05.\n\nThis is a single-center randomized study and will be conducted in 226 patients with 50-90% coronary artery stenosis on angiography. Afterward, randomly assigned, 113 patients will be tested using the roadmap system, and 113 patients will be tested without using the roadmap system. Methods for measuring FFR and iFR and all PCI will use standardized testing and procedure methods."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 226}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-11-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2022-12-27', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'iFR time', 'timeFrame': 'Through procedure completion, up to 24 hours', 'description': 'iFR time: the time interval between the pressure wire into the guiding catheter and the placement of the pressure wire on the distal of the blood vessel to measure iFR'}, {'measure': 'FFR time', 'timeFrame': 'Through procedure completion, up to 24 hours', 'description': 'FFR time: the time interval between the equalization of the pressure wire for FFR and the placement of the pressure wire on the distal of the blood vessel to measure FFR'}], 'secondaryOutcomes': [{'measure': 'Success rate of placement of the pressure wire on the distal of the blood vessel to measure iFR/FFR', 'timeFrame': 'Through procedure completion, up to 24 hours', 'description': 'The success rate of advancing pressure wire to a target vessel distally'}, {'measure': 'Use of contrast medium until the pressure wire is advanced to the distal end of the blood vessel', 'timeFrame': 'Through procedure completion, up to 24 hours', 'description': 'Use of contrast medium until the pressure wire is advanced to the distal end of the blood vessel'}, {'measure': 'The amount of contrast medium used until the pressure wire is advanced to the distal end of the blood vessel', 'timeFrame': 'Through procedure completion, up to 24 hours', 'description': 'The amount of contrast medium used until the pressure wire is advanced to the distal end of the blood vessel'}, {'measure': 'Total procedure time to assess functional significance using iFR/FFR pressure wire', 'timeFrame': 'Through procedure completion, up to 24 hours', 'description': 'Total procedure time between insertion and out of guiding catheter via a sheath'}, {'measure': 'Total procedure time', 'timeFrame': 'Through procedure completion, up to 24 hours', 'description': 'Total procedure time'}, {'measure': 'Total amount of contrast media usage', 'timeFrame': 'Through procedure completion, up to 24 hours', 'description': 'Total amount of contrast media usage'}, {'measure': 'Total dose of radiation exposure', 'timeFrame': 'Through procedure completion, up to 24 hours', 'description': 'Total dose of radiation exposure'}, {'measure': 'Complications related to the procedure', 'timeFrame': 'Through procedure completion, up to 24 hours', 'description': 'Complications related to the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iFR/FFR', 'Roadmap'], 'conditions': ['Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'In patients with 50-90% stenosis of the coronary artery, the coronary roadmap (dynamic roadmap) is performed when the conventional fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are performed. coronary roadmap system) to confirm the effectiveness of the function.', 'detailedDescription': 'In coronary angiography, 50% or more stenosis of the causative vessel is observed in a patient with stable angina pectoris (SAP) or 50% or more stenosis of a non-causative vessel is observed in acute coronary syndrome (ACS) Based on 0.90, if it is less than 0.89, PCI is performed, and if it is 0.90 or more, drug treatment is performed. When the pressure wire tests are performed, the pressure wire is inserted from the origin of the blood vessel through the lesion to the distal portion, and the pressure wire is placed at the distal end of the blood vessel for measurement. In this process, there are many cases where the pressure wire escapes the branch blood vessel or does not pass through well. It takes a long time to stand up and evaluate stenosis, and in many cases, an additional contrast medium is used to additionally check blood vessel travel and to check the position and condition of the pressure wire. To overcome this, the software roadmap installed in the cardiac fluoroscopy device of the cardiac catheterization room can be helpful. However, there are currently no studies related to roadmaps in coronary artery examination. Therefore, in this study, we want to evaluate the effectiveness of the roadmap when examining FFR and iFR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 19 years or older\n2. Patients with stable angina, including asymptomatic ischemic heart disease, who have 50-90% stenosis of the causative vessel by coronary angiography\n3. Acute coronary syndrome patients with multivessel disease and 50-90% stenosis of non-caused vessels that did not cause acute coronary syndrome\n4. Patients who voluntarily decided to participate in this study and gave written consent to the subject consent form\n\nExclusion Criteria:\n\n1. Patients with acute coronary syndrome and single vessel disease\n2. Patients who have undergone previous coronary artery bypass grafting\n3. Poor coronary blood flow (TIMI grade ≤ 2)\n4. If life expectancy is less than one year\n5. Women who are pregnant or wish to become pregnant'}, 'identificationModule': {'nctId': 'NCT05682118', 'acronym': 'ROAD-IFR', 'briefTitle': 'Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve: A Single-Center, Randomized Study (ROAD-IFR Trial)', 'orgStudyIdInfo': {'id': '9-2022-0134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tested using the roadmap system', 'description': 'tested using the roadmap system', 'interventionNames': ['Procedure: roadmap', 'Procedure: iFR/FFR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tested without using the roadmap system', 'description': 'tested without using the roadmap system.', 'interventionNames': ['Procedure: iFR/FFR']}], 'interventions': [{'name': 'roadmap', 'type': 'PROCEDURE', 'description': 'FFR and iFR tests using the roadmap system, or FFR and iFR tests without using the roadmap system.\n\nPressure wire into guiding catheter The equalization of the pressure wire with the aortic pressure(after placing the pressure wire on the tip of the guiding catheter and removal of contrast media by saline flushing) and the placement of the pressure wire on the distal of the blood vessel to measure iFR. After iFR measurement, the pressure wire was pulled back into the tip of the guiding catheter to check the presence of pressure drift. A final Pd/Pa between 0.97 and 1.03 is considered acceptable. Following confirming no pressure drift, a mode change will be done from iFR to FFR, and then a re-check of the time between the equalization of the pressure wire with the aortic pressure will be planned. In all lesions, FFR value were measured with hyperemia, achieved by intracoronary (IC) bolus injection of nicorandil (Sigmart®; Chugai Pharmaceutical Co., Ltd., Tokyo, Japan) 2 mg.', 'armGroupLabels': ['tested using the roadmap system']}, {'name': 'iFR/FFR', 'type': 'PROCEDURE', 'description': 'Patients undergoing pressure wire test with moderate stenosis. Pressure wire into guiding catheter The equalization of the pressure wire with the aortic pressure(after placing the pressure wire on the tip of the guiding catheter and removal of contrast media by saline flushing) and the placement of the pressure wire on the distal of the blood vessel to measure iFR. After iFR measurement, the pressure wire was pulled back into the tip of the guiding catheter to check the presence of pressure drift. A final Pd/Pa between 0.97 and 1.03 is considered acceptable. Following confirming no pressure drift, a mode change will be done from iFR to FFR, and then a re-check of the time between the equalization of the pressure wire with the aortic pressure will be planned. In all lesions, FFR value were measured with hyperemia, achieved by intracoronary (IC) bolus injection of nicorandil (Sigmart®; Chugai Pharmaceutical Co., Ltd., Tokyo, Japan) 2 mg.', 'armGroupLabels': ['tested using the roadmap system', 'tested without using the roadmap system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16995', 'city': 'Yongin', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yongcheol Kim, MD', 'role': 'CONTACT', 'email': 'yongcheol@yuhs.ac', 'phone': '+823151898967'}, {'name': 'Yongcheol Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Oh-Hyun Lee, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ji Woong Roh, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eui Im, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Deok-Kyu Cho, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Yongcheol Kim'}], 'centralContacts': [{'name': 'Yongcheol Kim, MD, PhD', 'role': 'CONTACT', 'email': 'yongcheol@yuhs.ac', 'phone': '+823151898967'}, {'name': 'Ji Woong Roh, MD, PhD', 'role': 'CONTACT', 'email': 'NOMGALDA@yuhs.ac', 'phone': '+823151898792'}], 'overallOfficials': [{'name': 'Yongcheol Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Yongcheol Kim', 'investigatorAffiliation': 'Yonsei University'}}}}